Evaluation of Shoulder Access Safety Using the NewMan Compression Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when it is used or when a pressure bandage is used.
The objectives of the study are to answer the following main questions: 1. Does the use of a compression device in shoulder access reduce the overall number of complications compared to an occlusive bandage? 2. Does the use of a compression device during shoulder access reduce the number of complications requiring surgical intervention compared to an occlusive bandage? 3. Does the use of a compression device during shoulder access reduce the number of hematomas in the access area compared to an occlusive bandage? The researchers will compare the number of complications associated with shoulder access when using a compression device and an occlusive bandage for the revascularization of femoral-popliteal segment occlusions of the lower extremity arteries. During the routine revascularization procedure, participants will undergo a catheterization of the brachial artery. Complications related to radiation therapy will be recorded by doctors within 72 hours of the intervention.
详细描述
The purpose of the study: to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the frequency of access complications when using the device or a pressure bandage.
Scientific hypotheses: 1. The use of the compression device in shoulder access has fewer complications compared to a pressure bandage. 2. The use of the compression device in shoulder access has fewer complications requiring surgical intervention compared to a pressure bandage. 3. The use of a compression device during shoulder access has a lower incidence of hematomas compared to a pressure bandage.
Inclusion criteria: an arterial diameter of at least 3 mm at the access site, indications for endovascular intervention on the lower extremity arteries, an age of 18 years or more, and patient consent to participate in the study.
Exclusion criteria: inability to perform access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, brachiocephalic trunk); height exceeding 180 cm; presence of concomitant pathology limiting patients' survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.), previously performed catheterization through the access artery.
The required sample size was calculated using the M. Blanda method for a study with increased accuracy. The required significance level (α) was 0.05, and the study's power was 95%. The estimated complication rates in the Brachial and NewMan groups were assumed to be 11% and 1%, respectively. Under these conditions, the estimated sample size was 141 patients. The planned loss rate during the study was 5%. Therefore, the minimum sample size was 148 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •arterial diameter at the access site of at least 3 mm
- •indications for endovascular intervention on the lower extremity arteries
- •age of 18 years or more, and patient consent to participate in the study
排除标准
- •inability to perform an access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, and brachiocephalic trunk)
- •height exceeding 180 cm; presence of concomitant pathology that limits patient survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.)
- •previous catheterizations performed through the access artery
研究组 & 干预措施
Brachial
Hemostasis is performed using a pressure bandage
干预措施: Hemostasis is performed using a pressure bandage (Procedure)
NewMan
Hemostasis is performed using the NewMan compression device
干预措施: Hemostasis is performed using the NewMan compression device (Procedure)
结局指标
主要结局
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Within 72 hours after artery catheterization
Number of participants with hematoma at the access point with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Within 72 hours after artery catheterization
Number of participants with Acute artery occlusion with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Within 72 hours after artery catheterization
Number of participants with Post-catheterization aneurysm that required surgery with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with Technical success of access
时间窗: Perioperative/Periprocedural
Number of participants with Technical success of access
Number of participants with Technical success of the index procedure
时间窗: Perioperative/Periprocedural
Number of participants with Technical success of the index procedure
Number of participants with Conversion to another access
时间窗: Perioperative/Periprocedural
Number of participants with Conversion to another access
次要结局
- Total number of complications(Within 72 hours after radial artery catheterization)
- Total number of complications that required surgery(Within 72 hours after radial artery catheterization)
研究者
Aleksandr V. Bocharov, PhD, MD
Clinical professor, PhD, MD
Pirogov Russian National Research Medical University